melatonin + Cognitive Behavioral Therapy for Insomnia

This investigational combination therapy, developed by Ache Laboratorios Farmaceuticos S.A., integrates the pharmacological agent melatonin with Cognitive Behavioral Therapy for Insomnia (CBT-I) for the treatment of insomnia disorder. Melatonin is a small molecule hormone that acts as an agonist at the melatonin receptors MT1 and MT2, which are primarily located in the suprachiasmatic nucleus of the hypothalamus and are responsible for regulating the circadian rhythm and promoting sleep onset. CBT-I is a multi-component behavioral intervention that includes sleep hygiene education, stimulus control, and sleep restriction to address the psychological and behavioral factors that maintain chronic insomnia. This combination is specifically being evaluated in a Phase III clinical trial (NCT02798367) in Brazil, targeting adults aged 55 years and older to determine if the synergy between pharmacological sleep induction and behavioral modification provides superior efficacy compared to CBT-I alone.

Other names

melatonin + CBT-Imelatonin + Cognitive Behavioral Therapy for InsomniaCBT-I + melatonin